Hackensack, New Jersey 07601


Purpose:

This is single-center, open-label, prospective study of telmisartan for the prevention of acute GVHD in approximately 60 subjects undergoing allogeneic HCT for treatment of a hematologic malignancy.


Study summary:

This is single-center, open-label, prospective study of telmisartan for the prevention of acute GVHD in approximately 60 subjects undergoing allogeneic HCT for treatment of a hematologic malignancy. Subjects will receive 160 mg Micardis brand telmisartan once daily, starting 2 days prior to HCT (day -2). Once the patient is discharged post-HCT, treatment will continue through Day +98 post-HCT for a total of 101 days. After treatment discontinuation on or before day +98 post-HCT, subjects will be followed for up to 6 months for primary and secondary endpoints.


Criteria:

Inclusion Criteria: - Diagnosis of: - Acute myeloid or lymphoid leukemia in remission, - Myelodysplastic syndrome, - Chronic lymphoid leukemia, - Non-Hodgkin lymphoma, - Hodgkin lymphoma, - Chronic myeloid leukemia in chronic or accelerated phase, - Myeloproliferative disorder, or - Multiple myeloma - Undergoing allogeneic HSC transplantation from a related or unrelated donor matched at least at 7 of 8 of the HLA-A, -B, -C, and DR loci ("8/8" or "7/8" match) - Undergoing allogeneic HSC transplantation after a myeloablative TBI-, busulfan-, or (non-myeloablative) melphalan-based pre-transplant conditioning regimen. Regimens for transplantation will include at one of the following agents, given in conjunction with fludarabine or cyclophosphamide: - Busulfan 130 mg/m2 iv daily x 2 (reduced intensity) or 4 days - TBI 150 cGy bid x8 doses (1200 Gy) - Melphalan 140 mg/m2. (Although melphalan is not a myeloablative regimen, it results in clinically significant mucositis and patients receiving this medication will be of considerable interest in the analysis of these data.) - Male or female patient age 18 years or older - Karnofsky performance status > 70% at time of initiation of pre-transplant conditioning - Transplantation-specific co-morbidity score of <5 at time of initiation of pre-transplant conditioning - Patients taking antihypertensive medications (including telmisartan) are eligible but the patient must discontinue treatment at least 48 hours prior to first dose of study medication - Capable of giving informed consent and having signed the informed consent form Exclusion Criteria: - Inability to provide informed consent - Subjects with known heart failure, advanced renal impairment requiring renal replacement therapy, or liver failure although these patients would most likely not be eligible for HCT. - Subjects taking ACE inhibitors, potassium supplements, or spironolactone (or any other potassium-sparing diuretics) who cannot discontinue use prior to initiation of study treatment OR who require a high-potassium diet - Patient unable to discontinue current hypertension medication for medical or other reasons for two days prior to starting telmisartan - Chronic symptomatic hypotension, volume depletion.


NCT ID:

NCT02338232


Primary Contact:

Principal Investigator
David Schwartz, MD. PhD
Hackensack University Medical Center

David Schwartz, MD, PhD
Email: dschwartz@fastmail.fm


Backup Contact:

N/A


Location Contact:

Hackensack, New Jersey 07601
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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